WHOOP · 1 month ago
Quality Systems & Regulatory Affairs Specialist, Digital Health
Boston, MA
Full-time
Onsite
Mid, Senior Level
$144K/yr - $197K/yr
4+ years expWHOOP is on a mission to unlock human performance and health span, and they are seeking a Quality Systems & Regulatory Affairs Specialist to join their Digital Health team. The role involves executing regulatory strategy and supporting QMS maintenance deliverables for WHOOP's software as a medical device products in a dynamic environment.
Consumer ElectronicsFitnessSportsWearablesWellness
Responsibilities
Interprets international regulatory and quality requirements for medical devices
Creates detailed regulatory and quality deliverables for international distribution of medical devices in countries such as Canada, Japan, EU, Brazil, etc
Prepares regulatory submissions for medical devices and maintains regulatory clearance through the product lifecycle
Interfaces with internal stakeholders such as engineering, product, and clinical to ensure regulatory and quality considerations are communicated throughout the product development lifecycle
Supports internal audits, gap assessments and updates to procedures for compliance with ISO 13485, IEC 62304, EU MDR and MDSAP requirements
Supports maintenance of the quality management system
Supports regulatory assessments of post-market changes and reportable events
Supports and leads internal and external audit activities to maintain QMS certifications
Qualification
Required
Bachelor's Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience
At least 4 years of experience in the medical device industry with regulatory submission experience, specifically in Brazil, Mexico, Japan and South Korea
Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision
Demonstrated history in achieving regulatory market authorization
Knowledge and experience with Software as a Medical Device, Cybersecurity, Verification & Validation, and global Digital Health policy
Demonstrated experience in and working knowledge of medical device regulations and standards (ISO 13485, MDSAP etc)
Passion for delivering impactful and high-quality products to people
Preferred
Experience with AI/ML is a plus
Benefits
Competitive base salaries
Meaningful equity
Benefits
A generous equity package
Company
WHOOP
WHOOP is a fitness tech company that offers wearables that track sleep, recovery, and performance.
501-1000 employees
H1B Sponsorship
WHOOP has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (18)
2023 (15)
2022 (5)
2021 (17)
2020 (6)
Funding
Current Stage
Late StageTotal Funding
$404.75MKey Investors
SoftBank Vision FundIVPFoundry Group
2026-01-15Undisclosed
2021-08-30Series F· $200M
2020-10-28Series E· $100M
Leadership Team
Will Ahmed
Founder & CEO
Aurelian Nicolae
Co-Founder & Chief Hardware Engineer
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-15
Company data provided by crunchbase